At Soterius, we deliver comprehensive clinical safety services supported by advanced technology solutions that ensure compliance, efficiency, and patient safety across the product lifecycle. From early-phase clinical development to post-marketing surveillance, our global team of safety experts provides structured, scalable, and high-quality pharmacovigilance support tailored to your organization’s needs.
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Clinical Safety Services > Case Intake Processing and Medical Review
Comprehensive Clinical Safety Services & Technology Offerings
Technology-Driven Pharmacovigilance Excellence
Our technology offerings are designed to enhance operational efficiency, data accuracy, and regulatory visibility. By integrating automation, workflow optimization, and real-time safety monitoring tools, we help organizations streamline processes and reduce manual burden. Our solutions support:
End-to-End Clinical Safety Services
Our clinical safety solutions are designed to manage risk proactively while maintaining strict regulatory compliance. We offer:
- Clinical and Post-Marketing Case Management– Accurate case intake, processing, medical review, and narrative writing aligned with global standards.
- Serious Adverse Event (SAE) Management – Timely assessment of seriousness, causality, and expectedness, with expedited reporting support.
- Signal Detection & Risk Management – Ongoing safety surveillance, signal evaluation, and risk mitigation strategies.
- Aggregate Report Writing – Preparation of PSURs, PBRERs, DSURs, RMPs, and other regulatory safety documents.
- Global Regulatory Oversight – Support from experienced QPPVs and Local Safety Managers across 60+ countries.
With 24/7 availability and inspection-ready quality systems, Soterius ensures seamless compliance with global pharmacovigilance regulations.
